Somatex
7 catalogue numbers from SOMACORE VERIFY S, listed by Biopsybell SRL, under Instrument, Biopsy. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Biopsybell SRL |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K130616 |
| Record published | 2016-08-01 |
| Record revised | 2025-04-29 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, blister of 5 |
| Sizes | Needle gauge 14 to 20 G; length 100 to 200 mm |
| Distribution end date | 2025-04-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SOMACORE VERIFY S | Needle Gauge 18 G | Withdrawn |
| SOMACORE VERIFY | Length 100 mm | Withdrawn |
| SOMACORE VERIFY | Needle Gauge 18 G | Withdrawn |
| SOMACORE VERIFY | Length 100 mm | Withdrawn |
| SOMACORE VERIFY S | Needle Gauge 16 G | Withdrawn |
| SOMACORE VERIFY | Length 100 mm | Withdrawn |
| SOMACORE VERIFY | Needle Gauge 20 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
Showing 12 of 692. All products under Instrument, Biopsy
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biopsybell S.R.L. | 510(k) number | 2021-03-22 | Class II | Vendor change control | Products labeled as sterile were distributed, but may not have been sterilized. | 50 units | 2026-02-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.